Prescription Drug Information: Omeprazole (Page 10 of 11)

14.8 Pediatric Studies for the Treatment of Symptomatic GERD, Treatment of EE due to Acid-Mediated GERD, and Maintenance of Healing of EE due to Acid-Mediated GERD

Treatment of Symptomatic GERD

The effectiveness of omeprazole for the treatment of symptomatic GERD in pediatric patients 2 to 16 years of age is based in part on data obtained from pediatric patients in an uncontrolled clinical study.

The study enrolled 113 pediatric patients 2 to 16 years of age with a history of symptoms suggestive of symptomatic GERD. Patients were administered a single dose of omeprazole (10 mg or 20 mg, based on body weight) for 4 weeks either as an intact capsule or as an open capsule in applesauce. Successful response was defined as no moderate or severe episodes of either pain-related symptoms or vomiting/regurgitation during the last 4 days of treatment. Results showed success rates of 60% (9/15; 10 mg omeprazole) and 59% (58/98; 20 mg omeprazole), respectively.

Treatment of EE due to Acid-Mediated GERD

In an uncontrolled, open-label dose-titration study, for the treatment of EE in pediatric patients 2 to 16 years of age required doses that ranged from 0.7 to 3.5 mg/kg/day (80 mg/day). Doses were initiated at 0.7 mg/kg/day. Doses were increased in increments of 0.7 mg/kg/day (if intraesophageal pH showed a pH of <4 for less than 6% of a 24-hour study). After titration, patients remained on treatment for 3 months. Forty-four percent of the patients were healed on a dose of 0.7 mg/kg body weight; most of the remaining patients were healed with 1.4 mg/kg after an additional 3 months’ treatment. EE was healed in 51 of 57 (90%) children who completed the first course of treatment in the healing phase of the study. In addition, after 3 months of treatment, 33% of the children had no overall symptoms, 57% had mild reflux symptoms, and 40% had less frequent regurgitation/vomiting.

Maintenance of Healing of EE due to Acid-Mediated GERD

In an uncontrolled, open-label study of maintenance of healing of EE in 46 pediatric patients, 1 to 16 years of age, 54% of patients required half the healing dose. The remaining patients increased the healing dose (0.7 to a maximum of 2.8 mg/kg/day) either for the entire maintenance period, or returned to half the dose before completion. Of the 46 patients who entered the maintenance phase, 19 (41%) had no relapse during follow-up (range 4 to 25 months). In addition, maintenance therapy in EE patients resulted in 63% of patients having no overall symptoms.

15 REFERENCES

1. Clinical and Laboratory Standards Institute (CLSI). Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria That Grow Aerobically; Approved Standard — Tenth Edition. CLSI Document M07-A10, Clinical and Laboratory Standards Institute, 950 West Valley Road, Suite 2500, Wayne, Pennsylvania, 19087, USA 2015.

16 HOW SUPPLIED/STORAGE AND HANDLING

Omeprazole delayed-release capsules, USP, 20 mg, are white body with black printing “20” and white cap with black printing “XI”. They are supplied as follows:


NDC 51407-641-01, bottle of 100 capsules (with desiccant)

NDC 51407-641-10, bottle of 1000 capsules (with desiccant)

Storage

Store omeprazole delayed-release capsules, USP in a tight container protected from light and moisture. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

17 PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling (Medication Guide and Instructions for Use).

Adverse Reactions

Advise patients to report to their healthcare provider if they experience any signs or symptoms consistent with:

  • Hypersensitivity reactions [see Contraindications ( 4)].
  • Acute Tubulointerstitial Nephritis [see Warnings and Precautions ( 5.2)].
  • Clostridium difficile -Associated Diarrhea [see Warnings and Precautions ( 5.3)].
  • Bone Fracture [see Warnings and Precautions ( 5.4)].
  • Cutaneous and Systemic Lupus Erythematosus [see Warnings and Precautions ( 5.6)].
  • Cyanocobalamin (Vitamin B-12) Deficiency [see Warnings and Precautions ( 5.8)].
  • Hypomagnesemia [see Warnings and Precautions ( 5.8)].

Drug Interactions

Advise patients to report to their healthcare provider if they start treatment with clopidogrel, St. John’s Wort or rifampin; or, if they take high-dose methotrexate [see Warnings and Precautions ( 5.7, 5.10, 5.12)].

Administration

  • Take omeprazole delayed-release capsules before meals.
  • Antacids may be used concomitantly with omeprazole delayed-release capsules.
  • Missed doses: If a dose is missed, administer as soon as possible. However, if the next scheduled dose is due, do not take the missed dose, and take the next dose on time. Do not take two doses at one time to make up for a missed dose.
  • Swallow omeprazole delayed-release capsules whole; do not chew.
  • For patients unable to swallow an intact capsule, omeprazole delayed-release capsules can be opened and administered in applesauce, as described in the Medication Guide.

Medication Guide

Omeprazole Delayed-Release Capsules, USP

(oh-MEE-pray-zole)

Read this Medication Guide before you start taking omeprazole delayed-release capsules and each time you get a refill. There may be new information. This information does not take the place of talking with your doctor about your medical condition or your treatment.

What is the most important information I should know about omeprazole delayed-release capsules?

You should take omeprazole delayed-release capsules exactly as prescribed, at the lowest dose possible and for the shortest time needed.

Omeprazole delayed-release capsules may help your acid-related symptoms, but you could still have serious stomach problems. Talk with your doctor.

Omeprazole delayed-release capsules can cause serious side effects, including:

  • A type of kidney problem (acute tubulointerstitial nephritis). Some people who take proton pump inhibitor (PPI) medicines, including omeprazole delayed-release capsules, may develop a kidney problem called acute tubulointerstitial nephritis that can happen at any time during treatment with omeprazole delayed-release capsules. Call your doctor if you have a decrease in the amount that you urinate or if you have blood in your urine.
  • Diarrhea. Omeprazole delayed-release capsules may increase your risk of getting severe diarrhea. This diarrhea may be caused by an infection (Clostridium difficile) in your intestines.
  • Call your doctor right away if you have watery stool, stomach pain, and fever that does not go away.
  • Bone fractures. People who take multiple daily doses of PPI medicines for a long period of time (a year or longer) may have an increased risk of fractures of the hip, wrist, or spine. You should take omeprazole delayed-release capsules exactly as prescribed, at the lowest dose possible for your treatment and for the shortest time needed. Talk to your doctor about your risk of bone fracture if you take omeprazole delayed-release capsules.
  • Certain types of lupus erythematosus. Lupus erythematosus is an autoimmune disorder (the body’s immune cells attack other cells or organs in the body). Some people who take proton PPI medicines, including omeprazole delayed-release capsules, may develop certain types of lupus erythematosus or have worsening of the lupus they already have. Call your doctor right away if you have new or worsening joint pain or a rash on your cheeks or arms that gets worse in the sun. Omeprazole delayed-release capsules can have other serious side effects. See “What are the possible side effects of omeprazole delayed-release capsules?”

What are omeprazole delayed-release capsules?

Omeprazole delayed-release capsules are a prescription medicine called a proton pump inhibitor (PPI). Omeprazole delayed-release capsules reduces the amount of acid in your stomach.

Omeprazole delayed-release capsules are used in adults:

  • for up to 8 weeks for the healing of duodenal ulcers. The duodenal area is the area where food passes when it leaves the stomach.
  • with certain antibiotics for 10 to 14 days to treat an infection caused by bacteria called H. pylori. If needed, your doctor may decide to prescribe another 14 to 18 days of omeprazole delayed-release capsules by itself after the antibiotics. Sometimes H. pylori bacteria can cause duodenal ulcers. The infection needs to be treated to prevent the ulcers from coming back.
  • for up to 8 weeks for healing stomach ulcers.
  • for up to 4 weeks to treat heartburn and other symptoms that happen with gastroesophageal reflux disease (GERD).

    GERD happens when acid in your stomach backs up into the tube (esophagus) that connects your mouth to your stomach. This may cause a burning feeling in your chest or throat, sour taste, or burping.

  • for up to 8 weeks to heal acid-related damage to the lining of the esophagus (called erosive esophagitis or EE). If needed, your doctor may decide to prescribe another 4 weeks of omeprazole delayed-release capsules.
  • to maintain healing of the esophagus. It is not known if omeprazole delayed-release capsules are safe and effective when used for longer than 12 months (1 year) for this purpose.
  • for the long-term treatment of conditions where your stomach makes too much acid. This includes a rare condition called Zollinger-Ellison Syndrome.

For children 2 to 16 years of age, omeprazole delayed-release capsules are used:

  • for up to 4 weeks to treat heartburn and other symptoms that happen with gastroesophageal reflux disease (GERD).
  • for up to 8 weeks to treat gastroesophageal reflux disease (GERD) with acid-related damage to the lining of the esophagus [called erosive esophagitis (or EE) due to acid-mediated GERD].
  • to maintain healing of the esophagus. It is not known if omeprazole delayed-release capsules are safe and effective when used longer than 12 months (1 year) for this purpose.

It is not known if Omeprazole Delayed-Release capsules is safe and effective in children less than 1 month of age.

Who should not take omeprazole delayed-release capsules?

Do not take omeprazole delayed-release capsules if you:

  • are allergic to omeprazole or any of the ingredients in omeprazole delayed-release capsules. See the end of this Medication Guide for a complete list of ingredients in omeprazole delayed-release capsules.
  • are allergic to any other proton pump inhibitor (PPI) medicine.
  • are taking a medicine that contains rilpivirine (EDURANT, COMPLERA) used to treat HIV-1 (Human Immunodeficiency Virus).

What should I tell my doctor before taking omeprazole delayed-release capsules?

Before taking omeprazole delayed-release capsules, tell your doctor about all of your medical conditions, including if you:

  • have low magnesium levels, low calcium levels and low potassium levels in your blood.
  • have liver problems
  • have any other medical conditions
  • are pregnant or plan to become pregnant. It is not known if omeprazole delayed-release capsules will harm your unborn baby.
  • are breastfeeding or plan to breastfeed. Omeprazole passes into your breast milk. Talk to your doctor about the best way to feed your baby if you take omeprazole delayed-release capsules.
  • Tell your doctor about all of the medicines you take including prescription and over-the-counter medicines, vitamins and herbal supplements. Omeprazole delayed-release capsules may affect how other medicines work, and other medicines may affect how omeprazole delayed-release capsules work. Especially tell your doctor if you take an antibiotic that contains clarithromycin or amoxicillin, or if you take clopidogrel (Plavix), methotrexate (Otrexup, Rasuvo, Trexall), St. John’s Wort (Hypericum perforatum), or rifampin (Rimactane, Rifater, Rifamate).

Know the medicines that you take. Keep a list of them to show your doctor and pharmacist when you get a new medicine.

How should I take omeprazole delayed-release capsules?

  • Take omeprazole delayed-release capsules exactly as prescribed by your doctor.
  • Do not change your dose or stop omeprazole delayed-release capsules without talking to your doctor.
  • Omeprazole delayed-release capsules are usually taken 1 time each day. Your doctor will tell you the time of day to take omeprazole delayed-release capsules, based on your medical condition.
  • Take omeprazole delayed-release capsules before a meal.
  • Antacids may be taken with omeprazole delayed-release capsules.

Omeprazole delayed-release capsules

  • Swallow omeprazole delayed-release capsules whole. Do not chew or crush omeprazole delayed-release capsules.
  • If you have trouble swallowing a whole capsule, you can open the capsule and take the contents in applesauce. See the “Instructions for Use” at the end of this Medication Guide for instructions on how to take omeprazole delayed-release capsules with applesauce.

    If you miss a dose of omeprazole delayed-release capsules, take it as soon as you remember. If it is almost time for your next dose, do not take the missed dose. Take the next dose at your regular time. Do not take 2 doses at the same time to make up for the missed dose.

If you take too much omeprazole delayed-release capsules, call your doctor or your poison control center at 1-800-222-1222 right away or go to the nearest emergency room.

What are the possible side effects of omeprazole delayed-release capsules?

Omeprazole delayed-release capsules can cause serious side effects, including:

  • See “What is the most important information I should know about omeprazole delayed-release capsules?”
  • Vitamin B-12 deficiency. Omeprazole delayed-release capsules reduces the amount of acid in your stomach. Stomach acid is needed to absorb vitamin B-12 properly. Talk with your doctor about the possibility of vitamin B-12 deficiency if you have been on omeprazole delayed-release capsules for a long time (more than 3 years).
  • Low magnesium levels in your body. This problem can be serious. Low magnesium can happen in some people who take a PPI medicine for at least 3 months. If low magnesium levels happen, it is usually after a year of treatment.

You may or may not have symptoms of low magnesium. Tell your doctor right away if you develop any of these symptoms:

  • seizures
  • dizziness
  • abnormal or fast heart beat
  • jitteriness
  • jerking movements or shaking (tremors)
  • muscle weakness
  • spasms of the hands and feet
  • cramps or muscle aches
  • spasm of the voice box

Your doctor may check the level of magnesium in your body before you start taking omeprazole delayed-release capsules or during treatment if you will be taking omeprazole delayed-release capsules for a long period of time.

Stomach growths (fundic gland polyps). People who take PPI medicines for a long time have an increased risk of developing a certain type of stomach growths called fundic gland polyps, especially after taking PPI medicines for more than 1 year.

Severe skin reactions. Omeprazole delayed-release capsules can cause rare but severe skin reactions that may affect any part of your body. These serious skin reactions may need to be treated in a hospital and may be life threatening:

  • Skin rash which may have blistering, peeling or bleeding on any part of your skin (including your lips, eyes, mouth, nose, genitals, hand or feet)
  • You may also have fever, chills, body aches, shortness of breath, or enlarged lymph nodes.

Stop taking omeprazole delayed-release capsules and call your doctor right away. These symptoms may be the first sign of a severe skin reaction.

The most common side effects with omeprazole delayed-release capsules in adults and children include:

  • Headache
  • Nausea
  • vomiting
  • stomach pain
  • diarrhea
  • gas

In addition to the side effects listed above, the most common side effects in children 1 to 16 years of age include:

  • respiratory system event
  • fever

Other side effects:

Serious allergic reactions. Tell your doctor if you get any of the following symptoms with omeprazole delayed-release capsules:

  • rash
  • throat tightness
  • face swelling
  • difficulty breathing

Your doctor may stop omeprazole delayed-release capsules if these symptoms happen. Tell your doctor if you have any side effect that bothers you or that does not go away. These are not all the possible side effects with omeprazole delayed-release capsules. For more information, ask your doctor or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store omeprazole delayed-release capsules?

  • Store omeprazole delayed-release capsules at room temperature between 68°F to 77°F (20°C to 25°C).
  • Keep the container of omeprazole delayed-release capsules closed tightly.
  • Keep the container of omeprazole delayed-release capsules dry and away from light.

Keep omeprazole delayed-release capsules and all medicines out of the reach of children.

General information about the safe and effective use of omeprazole delayed-release capsules.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use omeprazole delayed-release capsules for a condition for which it was not prescribed. Do not give omeprazole delayed-release capsules to other people, even if they have the same symptoms you have. It may harm them.

This Medication Guide summarizes the most important information about omeprazole delayed-release capsules. For more information, ask your doctor. You can ask your doctor or pharmacist for information that is written for healthcare professionals.

What are the ingredients in omeprazole delayed-release capsules?

Active ingredient: Omeprazole

Inactive ingredients: The 10 mg and 20 mg capsule contains the following inactive ingredients: colloidal silicon dioxide, crospovidone, dibasic sodium phosphate, hypromellose, magnesium hydroxide granules (with corn starch), methacrylicacid and ethyl acrylate copolymer dispersion, polyethylene glycol, polysorbate 80, polyvinyl alcohol, polyvinyl alcohol-polyethylene glycol graft copolymer, purified water, silicon dioxide, sodium lauryl sulfate, sugar spheres (sucrose, corn starch, and purified water), talc, and titanium dioxide. The capsule shells for the 10 and 20 mg have the following inactive ingredients: gelatin and titanium dioxide. The ink used for printing contains: black iron oxide, potassium hydroxide, propylene glycol, shellac, and strong ammonia solution.

Instructions for Use

Omeprazole Delayed-Release Capsules, USP

Taking omeprazole delayed-release capsules with applesauce:

  1. Place 1 tablespoon of applesauce into a clean container.
  2. Carefully open the capsule and sprinkle the pellets onto the applesauce. Mix the pellets with the applesauce.
  3. Swallow the applesauce and pellet mixture right away. Do not chew or crush the pellets. Do not store the applesauce and pellet mixture for later use.

The brands listed are the registered trademarks of their respective owners and are not trademarks of Xiromed, LLC.

For more information, call Xiromed, LLC. at 1-844-XIROMED (1-844-947-6633).

This Medication Guide has been approved by the U.S. Food and Drug Administration.

Finished Drug Product Manufactured for Xiromed, LLC.

Florham Park, NJ 07932

Rev.February 2022

PI150-06

Marketed/Packaged by:

GSMS, Inc.

Camarillo, CA USA 93012

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